As bio statistician, you will be responsible for supporting the clinical teams in the design of new clinical studies for the early clinical evaluation of new drug candidates. In particular, you will:
- Act as functional expert in clinical project sub teams
- Participate in the clinical study protocol writing of new phase I-II-III clinical studies (design, sample size, assessments and statistical methodology) and be involved in the setup of the data capture tools
- Interface with the CRO statistician to discuss statistical data analysis, write the SAP, perform a thorough QC of the derived data and TLFs provided by the CRO, and provide input in the study reporting
- Take ownership of the database and interface with the CRO on database management
- Manage additional data analyses, in close interaction with functional experts involved in the clinical study
- The successful candidate is a Master or a PhD in sciences (e.g. biomedical sciences, mathematics, biology…) with an additional Master in (Bio)Statistics and has at least 10 years of experience in clinical drug development.
- He (she) enjoys working in cross-functional teams and has excellent oral and written communication skills especially in English (writing and speaking).